Biogen has announced that its biosimilar, Tofidence (tocilizumab-bavi), has been approved by the US Food and Drug Administration (FDA) to treat certain forms of arthritis.
The monoclonal antibody, developed by Bio-Thera, is a version of Genentech’s Actemra and now the first tocilizumab biosimilar to gain approval from the US regulator.
Tofidence, which is administered as an intravenous infusion, is specifically authorised to treat patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs and those aged two years and older with polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis.
A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
Biogen notes that spending on therapies for autoimmune diseases has “consistently increased” by 10% to 25% each year over the past decade.
Ian Henshaw, global head of biosimilars at Biogen, said: “The approval of Tofidence in the US marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies.
“With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for healthcare systems and an increase in physician choice and patient access to biologics.”
The FDA’s decision was supported by evidence confirming the similarity of Tofidence to Actemra.
Multiple lots manufactured for each product were compared across a broad range of different product quality attributes, with the results confirming similarity in the structural and functional features of Tofidence and Actemra, including those known to impact safety and efficacy.
The comparative clinical data to support the approval included results from a pharmacokinetic study in healthy individuals, which confirmed similar exposure following intravenous administration.
Additionally, a study in patients with rheumatoid arthritis who were inadequately controlled by methotrexate demonstrated similarity between the two products in efficacy, safety and immunogenicity endpoints.
Biogen and Bio-Thera signed a global commercialisation agreement for Tofidence in 2021. As part of the deal, Biogen has exclusive regulatory, manufacturing and commercial rights to the biosimilar in all countries excluding China (including Hong Kong and Macau and Taiwan).
In a statement, Biogen said it is “currently evaluating the potential launch timeline for Tofidence in the US”.